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Quality of life is maintained with ixazomib maintenance in post-transplant newly diagnosed multiple myeloma: The TOURMALINE-MM3 trial

F. Schjesvold, H. Goldschmidt, V. Maisnar, I. Spicka, N. Abildgaard, P. Rowlings, L. Cain, D. Romanus, K. Suryanarayan, V. Rajkumar, D. Odom, A. Gnanasakthy, M. Dimopoulos

. 2020 ; 104 (5) : 443-458. [pub] 20200222

Language English Country Great Britain

Document type Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial

Persistent link   https://www.medvik.cz/link/bmc21012639

Grant support
Takeda Pharmaceuticals

OBJECTIVES: Health-related quality of life (HRQoL) is particularly important during maintenance therapy (MT) in newly diagnosed multiple myeloma post-transplant, when disease symptoms are limited. METHODS: We assessed HRQoL in patients randomised to 26 cycles of MT (ixazomib vs placebo) in TOURMALINE-MM3 (NCT02181413). RESULTS: The characteristics at study entry were well-balanced between ixazomib (n = 386) and placebo (n = 251) arms. At study entry, EORTC QLQ-C30 and MY20 scores were high for functional scales and low for symptom scales and were comparable with those of the general population. Changes in subscale scores across intervals, analysed over 30 four-week intervals using a linear mixed-effects model, were generally small and similar between arms for the EORTC QLQ-C30 Global Health Status/QoL, Physical Functioning, and Pain subscales and EORTC QLQ-MY20 Disease Symptoms subscale and Peripheral Neuropathy item. EORTC QLQ-C30 Nausea/Vomiting and Diarrhoea subscales were consistently worse for ixazomib than for placebo, in line with the ixazomib toxicity profile. Even when least-squares mean differences between arms were statistically significant, none reached the established minimal important clinical difference of 10 in multiple myeloma. CONCLUSIONS: In addition to improvement in progression-free survival with ixazomib, HRQoL was maintained in both arms. Active treatment with ixazomib did not have an adverse impact on HRQoL.

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$a Schjesvold, Fredrik $u Oslo Myeloma Center, Oslo University Hospital, Oslo, Norway $u KG Jebsen Center for B cell malignancies, University of Oslo, Oslo, Norway
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$a OBJECTIVES: Health-related quality of life (HRQoL) is particularly important during maintenance therapy (MT) in newly diagnosed multiple myeloma post-transplant, when disease symptoms are limited. METHODS: We assessed HRQoL in patients randomised to 26 cycles of MT (ixazomib vs placebo) in TOURMALINE-MM3 (NCT02181413). RESULTS: The characteristics at study entry were well-balanced between ixazomib (n = 386) and placebo (n = 251) arms. At study entry, EORTC QLQ-C30 and MY20 scores were high for functional scales and low for symptom scales and were comparable with those of the general population. Changes in subscale scores across intervals, analysed over 30 four-week intervals using a linear mixed-effects model, were generally small and similar between arms for the EORTC QLQ-C30 Global Health Status/QoL, Physical Functioning, and Pain subscales and EORTC QLQ-MY20 Disease Symptoms subscale and Peripheral Neuropathy item. EORTC QLQ-C30 Nausea/Vomiting and Diarrhoea subscales were consistently worse for ixazomib than for placebo, in line with the ixazomib toxicity profile. Even when least-squares mean differences between arms were statistically significant, none reached the established minimal important clinical difference of 10 in multiple myeloma. CONCLUSIONS: In addition to improvement in progression-free survival with ixazomib, HRQoL was maintained in both arms. Active treatment with ixazomib did not have an adverse impact on HRQoL.
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$a Goldschmidt, Hartmut $u Department of Internal Medicine V, University Medical Hospital and National Center of Tumor Diseases, University of Heidelberg, Heidelberg, Germany
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$a Maisnar, Vladimir $u Department of Medicine-Hematology, Charles University Hospital, Hradec Králové, Czech Republic
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$a Spicka, Ivan $u Department of Hematology, Charles University, Prague, Czech Republic
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$a Abildgaard, Neils $u Department of Hematology, Odense University Hospital, University of Southern Denmark, Odense, Denmark
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$a Rowlings, Philip $u Department of Hematology, School of Medicine & Public Health, University of Newcastle, Waratah, New South Wales, Australia
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$a Cain, Lauren $u Statistical and Quantitative Sciences, Takeda Pharmaceuticals, Cambridge, MA, USA
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$a Romanus, Dorothy $u Global Outcomes Research, Takeda Pharmaceuticals, Cambridge, MA, USA
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$a Suryanarayan, Kaveri $u Oncology Clinical Research, Takeda Pharmaceuticals, Cambridge, MA, USA
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$a Rajkumar, Vincent $u Division of Hematology, Department of Internal Medicine, Mayo Clinic, Rochester, MN, USA
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$a Odom, Dawn $u Biostatistics, RTI Health Solutions, Research Triangle Park, NC, USA
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$a Gnanasakthy, Ari $u Patient-Centered Outcomes Assessment, RTI Health Solutions, Research Triangle Park, NC, USA
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$a Dimopoulos, Meletios $u Department of Clinical Therapeutics, Hematology & Medical Oncology, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece
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